GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)

The GX1 Radiofrequency Generator is a 50-watt RF lesion generator that delivers electrical power to radiofrequency probes to create lesions for pain treatment and functional neurosurgical procedures. It is a small, portable device (14.3" W × 10.8" H × 12.5" D, 24 lbs) that operates on standard household electrical supply (100–240 VAC) and continuously monitors and controls power output based on temperature and impedance measurements at the treatment site.

The GX1 Generator matches its predicate (G4) in core specifications: both deliver 0–50 W at 480 kHz ±3%, support voltage-controlled (0–5 V) and current-controlled (0–10 mA) stimulation modes, monitor impedance from 0–3000 ohms, and control ablation temperature from 37–90°C. Key differences are that GX1 adds Contact Quality Monitoring (CQM) and has a slightly expanded environmental operating pressure range (620–1060 hPa vs. 500–1060 hPa for G4). Both use identical design, materials, cleaning, sterilization methods, and packaging.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-2 (high-frequency surgical equipment safety), and ASTM D4169 (shipping container performance testing). Design verification and validation testing confirmed RF power output, voltage/current measurements, temperature control, and software functionality.

The GX1 is substantially equivalent because it employs the identical radiofrequency ablation technology and control methodology as the G4 predicate, with equivalent electrical specifications, output parameters, and clinical indications. The addition of Contact Quality Monitoring is an enhancement that does not change the fundamental mechanism of action. Comprehensive testing—electrical safety, EMC, RF performance, and design verification—confirmed the GX1 produces equivalent lesion sizes and meets all applicable standards, demonstrating no new safety or effectiveness concerns compared to the predicate.